General MedicationsORALGeneric

TIVICAY

DOLUTEGRAVIR SODIUM

Standard Dose

EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Discontinued

Summary

Approval overview TIVICAY is listed in Drugs@FDA under application 204790 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient DOLUTEGRAVIR SODIUM Form and strength TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor VIIV HLTHCARE Submission history Latest submission status date: 2025-10-28 00:00:00.

Structured Monograph

Clinical summary

Approval overview TIVICAY is listed in Drugs@FDA under application 204790 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient DOLUTEGRAVIR SODIUM Form and strength TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor VIIV HLTHCARE Submission history Latest submission status date: 2025-10-28 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Discontinued
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.